Procedural Accessory Kit recall
Procedural Accessory Kit Catalog Number: 9665R2
Why was Procedural Accessory Kit recalled?
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 2031038 UDI: 00860000210461
- Product
- Procedural Accessory Kit Catalog Number: 9665R2
- Recalling firm
- Busse Hospital Disposables, Inc.
- Quantity
- 250 units
- Distribution
- Nationwide
- Recall date
- June 8, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)